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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device enzyme immunoassay, phenobarbital
Product CodeDLZ
Regulation Number 862.3660
Device Class 2


Premarket Reviews
ManufacturerDecision
ORTHO-CLINICAL DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2023 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 7 7
High Test Results 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7 7

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